Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Caitlin Costello, MD
Photo of Caitlin Costello
Caitlin Costello

Description

Summary

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

Official Title

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

Keywords

Multiple Myeloma in Relapse Multiple Myeloma Multiple Myeloma of Bone Multiple Myeloma With Failed Remission Neoplasms, Plasma Cell HPN217

Eligibility

For people ages 18-100

Major Inclusion Criteria:

  1. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
  2. Measurable disease defined as at least one of the following:
  3. Serum M-protein ≥0.5 g/dL
  4. Urine M-protein ≥200 mg/24 hours
  5. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  7. Adequate hematologic status, including:
  8. Absolute neutrophil count (ANC) ≥1000 cells/μL
  9. Platelet count ≥50,000/μL (without transfusions)
  10. Hemoglobin ≥8 g/dL
  11. Adequate renal function, including:
  12. Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault
  13. Adequate hepatic function, including
  14. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
  15. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
  16. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

Major Exclusion Criteria:

  1. Prior exposure to BCMA-targeting agents (Part 2 only)
  2. Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Banner MD Anderson Cancer Center accepting new patients
    Gilbert Arizona 85234 United States

Lead Scientist at UCSD

  • Caitlin Costello, MD
    As a member of the Division of Blood and Marrow Transplantation, Dr Costello is dedicated to providing excellent care for patients with a variety of hematologic malignancies, with a specific focus in lymphoproliferative disorders and bone marrow transplantation. Dr Costello’s research interests focus particularly on the refinement of the management and treatment of multiple myeloma.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Harpoon Therapeutics
ID
NCT04184050
Phase
Phase 1/2
Study Type
Interventional
Last Updated